NCT03381586

QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Altor BioScience · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, pharmacokinetic study of ALT-803 administered as a subQ injection to healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALT-803	Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL and subjects randomized to Group B will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Timeline

• Start date: 2017-12-27
• Primary completion: 2018-03-13
• Completion: 2018-03-13
• First posted: 2017-12-22
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study